510(k) K071036

MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEM by Siemens Medical Solutions USA, Inc., Ultrasound DI — Product Code IYN

K071036 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc., Ultrasound DI for the device "MODIFICATION TO ACUSON X300 ULTRASOUND SYSTEM". The FDA issued a decision of Substantially Equivalent on May 16, 2007. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Siemens Medical Solutions USA, Inc., Ultrasound DI has 10 other 510(k) clearances on record.